(81 days)
The device is intended for medical purposes to provide mobility to persons restricted to a seated position.
The KAIYANG Steel Wheelchair is indoor / outdoor wheelchair that has a base with four-wheeled with a seat. The device can be disassembled for transport and it The device uses a standard sling type back and seat, the is foldable easily. upholstery fabric meets the California Technical Bulletin CAL 117 standard for flame retardant.
Here's an analysis of the provided text regarding the KAIYANG Steel Wheelchair, structured to address your specific questions.
It's important to note that this document is a 510(k) summary for a Class I medical device (mechanical wheelchair). For this class of device, the regulatory bar for demonstrating safety and effectiveness is generally met by showing substantial equivalence to a predicate device, rather than requiring extensive clinical trials with human readers, pathology, or highly specialized expert consensus panels as might be seen for higher-risk devices or AI algorithms.
Acceptance Criteria and Reported Device Performance
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|
| ANSI/RESNA WC vol. 1 | Meets applicable requirements |
| ISO 7176 Wheelchair Standards | Meets applicable requirements |
Explanation: The KAIYANG Steel Wheelchair states that it "meets the applicable performance requirements as specified in ANSI/RESNA WC vol. 1 and ISO 7176 Wheelchair Standards." These standards provide the acceptance criteria for mechanical wheelchairs, covering aspects like static, impact, and fatigue strength, braking, stability, and dimensions. The device's performance is reported as compliant with these standards.
2. Sample sized used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document does not explicitly state the sample size used for the performance testing. Performance testing for mechanical wheelchairs typically involves testing physical units of the device to the specified standards (e.g., loading, impact tests). The provenance of this test data would be from the manufacturer's testing facility (Guangdong Kaiyang Medical Technology Co., Ltd. in China), and it would be prospective in the sense that the manufacturer tested their device against the standards. It's not "data" in the sense of patient records or images.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
This information is not applicable to this type of device and submission. "Ground truth" in the context of expert consensus, pathology, or outcomes data is relevant for devices making diagnostic or treatment claims, or those using AI algorithms. For a mechanical wheelchair, the "ground truth" is defined by the objective, measurable parameters outlined in the ANSI/RESNA and ISO standards, which are physical properties and performance metrics. Compliance is assessed through engineering and mechanical testing, not expert medical review of cases.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not applicable. Adjudication methods involving multiple experts are used to resolve disagreements in subjective interpretations (e.g., imaging reads). The performance testing for a mechanical wheelchair against a standard is objective mechanical testing, where results are typically pass/fail based on predefined thresholds in the standards.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
There was no MRMC comparative effectiveness study and no AI component in this submission. This type of study is relevant for AI-powered diagnostic or assistive technologies where human performance is part of the evaluation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
There was no standalone algorithm performance study as there is no AI algorithm associated with this device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device's performance is primarily established by the objective, measurable criteria defined within the ANSI/RESNA WC vol. 1 and ISO 7176 Wheelchair Standards. These standards define acceptable levels of structural integrity, stability, braking performance, dimensions, and other physical requirements for a mechanical wheelchair. Compliance is demonstrated through physical testing against these predefined engineering specifications.
8. The sample size for the training set
There is no training set for this device submission. Training sets are used for machine learning models, which are not involved here.
9. How the ground truth for the training set was established
This question is not applicable as there is no training set for this device.
Summary of the Study provided:
The primary "study" presented in this 510(k) summary is the performance testing against recognized national and international standards for mechanical wheelchairs (ANSI/RESNA WC vol. 1 and ISO 7176). The document states that the KAIYANG Steel Wheelchair "meets the applicable performance requirements" of these standards.
The core of the K101999 submission is a demonstration of substantial equivalence to existing predicate devices (JMC612-FL318EPP and JMC612-FL418EPP). The comparison highlights identical intended use (mobility for persons restricted to a seated position) and similar structural features (foldable mainframe, removable armrests, swing-away footrest, flame-retardant upholstery). The main difference noted is the material of the frame (steel for the new device and one predicate, aluminum for the other predicate) and overall appearance, which are deemed not to affect safety. The FDA's letter confirms the determination of substantial equivalence.
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Guangdong Kaiyang Medical Technology Co., Ltd.,
China guồng Trai young
Yanfeng Industrial Area, Dali, Nanhai District, Foshan, China, 52823 h Tel: +86-757-85502506 Fax:+86-757-85502630 Email:ceirs.jen@msa.hinet.net
OCT 4 2010
510(k) SUMMARY "
Y”
K101999
Submitter's Name: Guangdong Kaiyang Medical Technology Co., Ltd. , Grangaong Tulyang Dali, Nanhai District, Foshan, China, 528231
July 2, 2010
Date summary prepared:
Device Name:
| Proprietary Name: | KAIYAN |
|---|---|
| Common or Usual Name: | Mechanic |
| Classification Name: | Mechanic |
IG Steel Wheelchair cal Wheelchair ical Wheelchair, Class I, 21 CFR 890.3850
Indications for Use:
The device is intended for medical purposes to provide mobility to persons restricted to a seated position.
Description of the device:
The KAIYANG Steel Wheelchair is indoor / outdoor wheelchair that has a base with four-wheeled with a seat. The device can be disassembled for transport and it The device uses a standard sling type back and seat, the is foldable easily. upholstery fabric meets the California Technical Bulletin CAL 117 standard for flame retardant.
Performance Testing:
KAIYANG Steel Wheelchair meets the applicable performance requirements as specified in ANSI/RESNA WC vol. 1 and ISO 7176 Wheelchair Standards.
Legally marketed device for substantial equivalence comparison:
hairean- --------------------------------------------------------------------------------------------------------------------------------------------------------------------
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Summary for substantial equivalence comparison:
From the above comparison table the intended use between the predicate devices (JMC612-FL318EPP and JMC612-FL418EPP) are the identical structure but made by different materials, steel for JMC612-FL318EPP and aluminum for JMC612-FL418EPP; and new device is made by steel structure. Mainframes of two devices are foldable. There are similar removable desk-length armrest and same swing-away detachable elevating footrest. Besides, back upholstery material is also the same resistance-ignitability fabric and also meets the California Technical standard for flame retardant. The C overall appearance differences are not safety aspect. Thus the new device is substantially equivalent to the predicate device.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus, which is a symbol often associated with medicine and healthcare. The caduceus is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Guangdong Kaiyang Medical Technology Co., Ltd. % Dr. Ke-Min Jen Official Correspondent Yanfeng Industrial Area, Dali, Nanhai District Foshan China 528231
4 2010 OCT
Re: K101999
Trade/Device Name: KAIYANG Steel Wheelchair Regulation Number: 21 CFR 890.3850 Regulation Name: Mechanical wheelchair Regulatory Class: I Product Code: IOR Dated: August 17, 2010 Received: August 25, 2010
Dear Dr. Jen:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21
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Page 2 - Dr. Ke-Min Jen
CFR Part 807): labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510 (K) Number ( If Known ): _________________________________________________________________________________________________________________________________________________
Device Name: KAIYANG Steel Wheelchair
Indications for Use:
Indications for USE:
The device is intended for medical purposes to provide mobility to persons restricted to a sitting position._
Over-The-Counter Use AND/OR Prescription Use (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE
S IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) |
|---|
| --------------------- |
Division of Surgical, Orthopedic,
and Restorative Devices
| 510(k) Number | K101999 |
|---|---|
| --------------- | --------- |
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§ 890.3850 Mechanical wheelchair.
(a)
Identification. A mechanical wheelchair is a manually operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.(b)
Classification. Class I (general controls).